Prostatic Arterial Embolization with SQUID (Ethylene Vinyl Alcohol Copolymer )

Centre Hospitalier Universitaire de Nice

Status: Completed

Conditions: Prostatic Hyperplasia, Benign

Treatments: Procedure: SQUID (Ethylene Vinyl Alcohol Copolymer ) administred to the participant with the intervention Prostatic Arterial Embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT05395299

21-PP-21

2021-A02956-35 (Registry Identifier)

Details and patient eligibility

About

The aim of this pilot study is to analyze the feasibility of prostatic embolization for the treatment of symptomatic benign prostatic hypertrophy with a non adhesive liquid embolic agent (Squid)

Full description

Microparticle prostatic embolization is an effective technique in the short and medium term in the treatment of symptoms related to benign prostatic hyperplasia. If this technique allows an improvement of the patients' symptoms, and fewer operative complications than urological interventions, on the other hand, the injection of arterial particles has several disadvantages: a random long-term durability mainly due to a revascularization of the embolized territories ; inferiority compared to urological treatments in terms of reduction of prostate volume and improvement of postoperative urodynamic tests; poor visualization of the embolization material, and a risk of injection of the particles into an artery supplying a non-target organ. Ethylene vinyl alcohol copolymer is a liquid embolism used for the endovascular treatment of cerebral arteriovenous malformations since 2005 and in specific extracerebral applications due to its advantageous physical properties (its viscous nature, its slow polymerization, its definitive and very distal occlusion, and its high fluoroscopic visibility). These properties would allow in prostatic embolization: to obtain better control during the injection and therefore to improve the safety of the embolization; to reduce the risk of recurrence; and to achieve a more intense prostatic ischemia and therefore to obtain a greater reduction in prostatic volume, and a better improvement in urodynamic tests. The aim of this pilot study is to analyze the feasibility of injecting this liquid embolic agent during the endovascular treatment of symptomatic benign prostatic hypertrophy. If this preliminary study is positive, a randomized phase III study could be undertaken to judge the results and the place of this technique in the treatment of symptoms related to benign prostatic hyperplasia.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Patient over 45 and under 80

• Benign prostatic hypertrophy with an obstructive syndrome of the lower urinary tract intolerant or refractory to medical treatment (continued for 6 months)

• Indication of prostatic embolization.

• Prostate volume of more than 40 ml

  • Subject with an IPSS> 18 and a Qol> 3

• Affiliation to a social security scheme.

• Subject who has given informed consent to participate in the study.

Exclusion criteria patient with prostate cancer or suspected of having prostate cancer

• patient with neurological bladder or AUS of extra-prostatic origin
• detrusor dysfunction
• documented allergy to iodinated contrast media
• Hepatic insufficiency
• advanced arteritis
• severe renal failure with glomerular filtration rate <60 ml / min / 1.73 m2 body surface area
• inability to independently complete the self-questionnaires used in the study • acute or chronic prostatitis
• hydronephrosis
• diverticulum larger than 2 cm or bladder calculus
• ureteral stenosis
• active infectious syndrome
• major surgery in the four months preceding the inclusion visit
• Progressive cancer or for which the risk of progressive recovery is more than 50% in the next 5 years
• limited life expectancy
• Vulnerable persons defined in Articles L. 1121-5 to L.1121-8 and L.1122-1-2 of the Public Health Code (eg: persons deprived of their liberty, minors, protected adults, etc.)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Prostatic Arterial Embolization with SQUID (Ethylene Vinyl Alcohol Copolymer )

Experimental group

Description:

Injection at the level of the right and left prostate arteries of Squid until a complete occlusion of these arteries, and a filling of their intraprostatic branches

Treatment:

Procedure: SQUID (Ethylene Vinyl Alcohol Copolymer ) administred to the participant with the intervention Prostatic Arterial Embolization